The federal litigation overseeing thousands of IVC filter lawsuits filed against Cook Medical, Inc. is preparing for the proceeding’s first bellwether trials.
According to an Order issued in the U.S. District Court, Southern District of Indiana, on August 23rd, jury selection for the first trial will begin on October 23, 2017. The case selected for trial, Hill v. Cook Medical, Inc., et al, 1:14-cv-6016, was filed on behalf of woman who claims that Cook’s Celect blood clot filter migrated and perforated her vena cava and duodenum. After a previous attempt at removal failed, the IVC filter was retrieved two years later using advanced techniques. However, the plaintiff claims that she continues to suffer adverse effects related to her IVC filter complications.
Jury selection for the second bellwether trial is scheduled to start on April 30, 2018. That case, Gage v. Cook Medical, Inc., 1:14-cv-1875-RLY-TAB, was filed on behalf of a man who allegedly suffered perforation of his inferior vena cava due to a malfunctioning Gunther Tulip IVC filter.
Jury selection for the third trial is slated to begin on September 10, 2018. That case, Brand v. Cook Medical, Inc., 1:14-cv-6018-RLY-TAB. Involves a Celect IVC filter recipient who learned two years after the device was implanted that it had two fragmented legs. Doctors were unable to remove the filter on their first try. Four years later, she underwent an open surgery to retrieve the device. Though the filter was removed, doctors were unable to retrieve the fractured pieces.
IVC filters are implanted in the inferior vena cava, where they intercept blood clots before they can travel to the heart and lungs. They are indicated for use in patients who are at risk for pulmonary embolism, but who are unable to use standard blood-thinning medications. Both the Celect and Gunther Tulip filters are retrievable, and are designed to be removed once a patient is no longer at risk or blood clots.
Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. The first was issued in August 2010, and disclosed that the agency’s medical device database had logged more than 900 adverse event reports involving retrievable IVC filters, including reports of filter fracture, migration, and embolization.
In May 2014, the FDA reminded doctors to retrieve IVC filters as soon as medically possible to reduce the risk of patient harm.